Senior Regulatory Affairs SME

Job Description

ProSidian Seeks a Senior Regulatory Affairs SME | Healthcare and Life Sciences [HHS123028] - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Senior Consultant Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA’s mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases..

Seeking Senior Regulatory Affairs SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS.  This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary.

JOB OVERVIEW

Provide services and support as a Healthcare And Life Sciences (Senior Regulatory Affairs SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services  (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World).

RESPONSIBILITIES AND DUTIES - Senior Regulatory Affairs SME | Healthcare and Life Sciences [HHS123028]

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers  immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate as subject matter experts on Program Coordination Teams (PCTs)
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
• Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.
• Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• Provide subject matter expertise in regulatory affairs supporting MCM development pathways.
• Strategize innovative regulatory approaches and strategies to MCM development against emerging threats.
• Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges.
• Advise BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities

Qualifications

Desired Qualifications For Senior Regulatory Affairs SME | Healthcare and Life Sciences [HHS123028] (HHS123028) Candidates:

• At least 15 years of senior-level industry experience in regulatory affairs.
• Significant experience in managing high-level regulatory challenges and strategic initiatives.
• Extensive FDA engagement experience, including authoring regulatory documents

Education / Experience Requirements / Qualifications

• Master’s degree or higher in biology, microbiology, chemistry, toxicology, pharmacy, or related field.
• Advanced education must be paired with commensurate industry experience in regulatory affairs or pharmaceutical development

Skills Required

• Expertise in regulatory affairs related to medical countermeasures (MCMs), including vaccines, therapeutics, and diagnostic devices.
• Strong understanding of FDA processes, regulatory guidelines, and compliance requirements.
• Excellent communication and strategic advisory capabilities

Competencies Required

• Ability to develop innovative regulatory strategies for emerging threats.
• Strong leadership in addressing program-level regulatory challenges.
• Proficiency in authoring, reviewing, and managing regulatory submissions and documents

Ancillary Details Of The Roles

• Deliverables include work products related to regulatory affairs management and strategic guidance.
• Key role in regulatory planning for advanced BARDA projects and acquisition contracts.
• Advisory role in developing regulatory pathways for MCMs
• Involvement in strategic regulatory discussions and advising senior leadership at BARDA.
• Collaborate with teams to ensure compliance and alignment with regulatory requirements.
• Lead and participate in regulatory interactions with FDA and other authorities

Other Details

• Knowledge of Accenture Starting Point preferred.
• Ability to provide strategic advice on submission planning and regulatory publishing improvements.
• Advanced skills in risk analysis and benefit assessment for submission success.
• Engagement in BARDA’s mission to enhance regulatory readiness for medical countermeasure development.

#TechnicalCrossCuttingJobs #Consulting #Nuclear #GovernmentSupportServices #ProfessionalAnalyticalSupport #Jugaad #Copitas #PokaYoke

Additional Information

CORE COMPETENCIES

• Teamwork – ability to foster teamwork collaboratively as a participant, and effectively as a team leader
• Leadership – ability to guide and lead colleagues on projects and initiatives
• Business Acumen – understanding and insight into how organizations perform, including business processes, data, systems, and people
• Communication – ability to effectively communicate to stakeholders of all levels orally and in writing
• Motivation – persistent in pursuit of quality and optimal client and company solutions
• Agility – ability to quickly understand and transition between different projects, concepts, initiatives, or work streams
• Judgment – exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications
• Organization – ability to manage projects and activity, and prioritize tasks

------------ ------------ ------------

OTHER REQUIREMENTS

• Business Tools –  understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Business Tools – understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Commitment - to work with smart, interesting people with diverse backgrounds to solve the biggest challenges across private, public and social sectors
• Curiosity – the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together
• Humility – exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference
• Willingness - to constantly learn, share, and grow and to view the world as their classroom

------------ ------------ ------------

BENEFITS AND HIGHLIGHTS

ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That’s why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently include the following for Full Time Employees:

• Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. For medical and dental benefits, the Company contributes a fixed dollar amount each month towards the plan you elect. Contributions are deducted on a Pre-tax basis.
• Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans, including high-deductible health plans or PPOs. ||| Group Dental Health Insurance Benefits: ProSidian dental carriers - Delta, Aetna, Guardian, and MetLife.
• Group Vision Health Insurance Benefits:ProSidian offers high/low vision plans through 2 carriers: Aetna and VSP.
• 401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. A range of investment options are available with a personal financial planner to assist you. The Plan is a pre-tax Safe Harbor 401(k) Retirement Savings Plan with a company match.
• Vacation and Paid Time-Off (PTO) Benefits: Eligible employees use PTO for vacation, a doctor’s appointment, or any number of events in your life. Currently these benefits include Vacation/Sick days – 2 weeks/3 days | Holidays - 10 ProSidian and Government Days are given.
• Pre-Tax Payment Programs: Pre-Tax Payment Programs currently exist in the form of a Premium Only Plan (POP). These Plans offer a full Flexible Spending Account (FSA) Plan and a tax benefit for eligible employees.
• Purchasing Discounts & Savings Plans: We want you to achieve financial success. We offer a Purchasing Discounts & Savings Plan through The Corporate Perks Benefit Program. This provides special discounts for eligible employees on products and services you buy on a daily basis.
• Security Clearance: Due to the nature of our consulting engagements there are Security Clearance requirements for Engagement Teams handling sensitive Engagements in the Federal Marketplace. A Security Clearance is a valued asset in your professional portfolio and adds to your credentials.
• ProSidian Employee & Contractor Referral Bonus Program: ProSidian Consulting will pay up to 5k for all referrals employed for 90 days for candidates submitted through our Referral Program.
• Performance Incentives: Due to the nature of our consulting engagements there are performance incentives associated with each new client that each employee works to pursue and support.
• Flexible Spending Account: FSAs  help you pay for eligible out-of-pocket health care and dependent day care expenses on a pre-tax basis. You determine your projected expenses for the Plan Year and then elect to set aside a portion of each paycheck into your FSA.
• Supplemental Life/Accidental Death and Dismemberment Insurance: If you want extra protection for yourself and your eligible dependents, you have the option to elect supplemental life insurance. D&D covers death or dismemberment from an accident only.
• Short- and Long-Term Disability Insurance: Disability insurance plans are designed to provide income protection while you recover from a disability.

------------ ------------ ------------

ADDITIONAL INFORMATION - See Below Instructions On The Best Way To Apply

ProSidian Consulting is an equal opportunity employer and considers qualified applicants foremployment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor. All your information will be kept confidential according to EEO guidelines.

ProSidian Consulting has made a pledge to the Hiring Our Heroes Program of the U.S. Chamber of Commerce Foundation and the “I Hire Military” Initiative of The North Carolina Military Business Center (NCMBC) for the State of North Carolina. All applicants are encouraged to apply regardless of Veteran Status.

Furthermore, we believe in "HONOR ABOVE ALL"  - be successful while doing things the right way. The pride comes out of the challenge; the reward is excellence in the work.

FOR EASY APPLICATION USE OUR CAREER SITE LOCATED ON http://www.ProSidian.com/ OR SEND YOUR RESUME’S, BIOS, AND SALARY EXPECTATION / RATES TO CAREERS @ PROSIDIAN.COM.

ONLY CANDIDATES WITH REQUIRED CRITERIA ARE CONSIDERED.

Be sure to place the job reference code in the subject line of your email.  Be sure to include your name, address, telephone number, total compensation package, employment history, and educational credentials.

Risk Management | Compliance | Business Processes | IT Effectiveness | Engineering | Environmental | Sustainability | Human Capital